Ketoconazole

Product NDC
50090-1675
11-digit product format
500901675
Labeler code
50090
Product ID
50090-1675_6bfee3cb-d985-49de-864c-6377eeef75e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA075638
Marketing category
ANDA
Marketing start
2002-12-18
Marketing end
0000-00-00
Substance
KETOCONAZOLE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1675-02023-01-30C16284748780-1f386c649-fd08-0266-e053-dadaa90a7c1aKetoconazole Cream, 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1675-0Ketoconazole30 g in 1 TUBECREAM307
50090-1675-0Ketoconazole1 in 1 CARTONCREAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1675-0GM - Gram50090-1675992dad90-9a9d-4e30-8cf1-d3746a191ae312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1675KETOCONAZOLE CREAM [A-S MEDICATION SOLUTIONS]7Legacy NDC, 2 package rows20210617_4848af6a-26fb-49cd-a2f0-2b5d7f34e586.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
203088ketoconazole 2 % Topical CreamPSN4848af6a-26fb-49cd-a2f0-2b5d7f34e5867
203088ketoconazole 20 MG/ML Topical CreamSCD4848af6a-26fb-49cd-a2f0-2b5d7f34e5867
203088ketoconazole 2 % Topical CreamSY4848af6a-26fb-49cd-a2f0-2b5d7f34e5867

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1675-0500901675001 TUBE in 1 CARTON (50090-1675-0) > 30 g in 1 TUBE1 tube2015-01-300000-00-00NoNoCurrent